eNews re IRB Review

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HSD Changes are Here!

Welcome to a special edition of the HSD eNews. It's a bit longer than usual, but we have many improvements and changes that we'd like to share with you.


NEW SOPs, Tools, and Policies

This spring HSD started a major project to write and/or revise procedures (i.e., standard operating procedures, or SOPs). This was prompted by two major federal audits. The project is also driven by the desire to increase clarity about requirements, IRB review consistency, and efficiency in training HSD staff and IRB members.

We are very pleased to announce the implementation of our first group of SOPs. Many of them are completely new; for example, we have never before had a document about expedited ("Minimal Risk") review, or about IRB review when more than one institution is engaged in a research project.

In parallel, we:

  • Developed several Worksheets as tools for researchers, HSD staff, and IRB members. For example, there is now a Worksheet about Human Subjects Research that will guide researchers through a self-determination about whether their project meets the regulatory definition of "human subjects research". See the New and Revised Documents at the end of this newsletter for a complete list of new/revised SOPs and new Worksheets.
  • Examined and revised some specific policies. Many (but not all) of these policies are relatively minor. However, these changes collectively should significantly reduce the time and/or requirements associated with IRB review for many researchers. The major changes are summarized below.

We look forward to releasing additional SOPs, tools, and policy changes during the next six months! One of these will be the revised Modification Form we described in the March eNews, and the policy about which investigators are to be listed on applications and forms.  We expect these to be implemented later this summer.

 


 

Summary of Policy Changes

Definition of Research

Activities that are not "research" as defined by the federal human subjects regulations do not require IRB review or exempt determination. The UW allows researchers to self-determine whether their projects are "research".

Policy change. Revised or new definitions (interpretations) are now available for each component of the federal definition of "research". (See the WORKSHEET Human Subjects Research, Section 2.)

Significance. It will be easier for researchers to self-determine whether their activities are "research".

Eligibility for Exempt Status

Exempt status means that a project is human subjects research but that it doesn't need to comply with the federal human subjects regulations. Research qualifies for exempt status when it involves no more than minimal risk to the participants and all of the research procedures fall into one or more specific categories.

Policy changes. Changes related to the interpretation of "minimal risk" are being implemented:

  1. Research involving prisoners is no longer automatically excluded from exempt status, although several important limitations apply. (See SOP Exempt Determination, Section 6.2.1.)
  2. Research involving "third party" subjects is no longer automatically excluded from exempt status. (See SOP Exempt Determination, Section 6.6.)
  3. Research involving deception is no longer automatically excluded from exempt status, although some limitations apply. (See SOP Exempt Determination, Section 6.7.)
  4. Though HSD continues to promote the use of a consent process in exempt research, HSD no longer requires exempt research to provide subjects with certain specific information.

Significance. Collectively, these changes mean that more research will qualify for exempt status.

Eligibility of Modifications for Expedited Review ("Minimal Risk" Review)

Federal regulations allow modifications for studies that are normally reviewed by a full IRB committee to be reviewed by a single IRB member (expedited or "Minimal Risk" review) instead of the full IRB, when the modification involves no more than a minor change. The regulations do not define "minor change".

Policy change. HSD has developed a definition of "minor change". (See SOP Expedited Review, Section 3.3.)

Significance. This means increased predictability in how modifications are reviewed.

Triage Process

HSD Staff assess IRB and exempt applications before review, to ensure that applications are complete. Occasionally the staff notice that an application qualifies for a "lower" level of review. For example, the project described in a Minimal Risk application might qualify for exempt status.

Policy changes.

  1. All new IRB and exempt applications will now be routinely assessed by HSD staff, to identify the "lowest" appropriate level of review. Whenever possible, that review will be conducted using the materials provided by the researcher, even when the application form is not the "correct" form.
  2. All new applications reviewed by a full IRB: when the IRB grants approval, it will also determine whether the subsequent Status Report and Modification reviews can be reviewed by the expedited (Minimal Risk) procedure instead of requiring the full IRB.
  3. All Status Reports reviewed by a full IRB: when the IRB grants approval, it will also determine whether subsequent Status Reports can be reviewed by the expedited (Minimal Risk) procedure instead of requiring the full IRB, or whether the IRB file can be closed.

Significance. Unnecessary applications (i.e., for activities that are not Human Subjects Research) will be triaged and returned before beginning the review process. More studies will qualify for exempt status or expedited (Minimal Risk) review.

Research Collaborations or Multiple Performance Sites

UW research projects may involve multiple non-UW institutions, locations, and individuals. The default position of the federal regulations and the UW is that each institution engaged in a research project must provide IRB review and approval of its own participation in the research. This is called "dual review". Until now, the UW has been willing to reduce dual review by allowing other institutions to rely upon the UW IRB but we have been unwilling to defer review to other IRBs.

Policy change.

  1. The UW is committed to reducing (as appropriate) duplicate reviews due to the engagement of multiple institutions, through the use of cooperative agreements, central IRBs, and study-specific agreements with IRBs at other institutions. (See SOP Research Collaborations or Multiple Performance Sites, Section 2.4.)
  2. The UW IRB is willing to rely upon the review of another institution's IRB, in certain circumstances. (See SOP Research Collaborations or Multiple Performance Sites, Section 7.)
  3. When dual review is unavoidable, UW researchers will no longer be required to provide documentation of the other IRB's approval in order to obtain UW IRB approval. However, UW researchers are still responsible for obtaining and maintaining documentation of all required IRB approvals in their research records, which are subject to post-approval monitoring by HSD.

Significance. More UW studies involving non-UW collaborations will require review by only one IRB. When more than one IRB must be involved, there will be fewer intractable inconsistencies between the IRBs. UW IRB approval will be granted more quickly because the prior need to provide the UW with documentation of approval of other IRBs was typically the rate-limiting step in the UW IRB approval process.

Grant Applications

Federal regulations require the IRB to compare for consistency the information contained in the IRB application with the information in the grant application that is funding the research.

Policy changes.

  1. It is no longer necessary for every discrepancy between a grant application and an IRB application to be identified and resolved by the IRB. Instead, the consistency review will focus only on the specific information relevant to IRB review and approval. (See SOP Funding Review, Section 5.1.1.)
  2. It is no longer necessary to provide a complete copy of a center, program, or institutional training grant application when such grants provide support for a research project. Instead, specific sections are required. (This will significantly reduce the amount of paper and copying required for these projects.)

Significance. There will be reduced "back and forth" on the consistency issue. Also, there will be a significantly reduced amount of paper and copying for center, program, and training grants (which are exceptionally large).


New and Revised Documents

We generally release and post all new and revised documents on the last Friday of every month. In this special edition of HSD eNews, new and revised documents have been broken out by their general position in the review cycle. We welcome feedback and suggestions. (hsdforms@uw.edu)

 

Topic Is it Research with Human Subjects? (NEW)
Document(s) NEW: SOP Human Subjects Research; WORKSHEET Human Subjects Research
Description New SOP and Worksheet to help determine if your project is research with human subjects, according to the federal definitions.
Expected impact High
Related changes None
Link for more information See the documents themselves, or the article in the eNews.
Implementation date

June 28, 2013

 

Topic Is it Research with Human Subjects? (REVISED)
Document(s) REVISED: SOP Public Data Sets; FORM Use of Non-Identifiable Biological Specimens-Data; FORM Case Report Research-Self Determination; Case Report - IRB and HIPAA Requirements
Description These existing documents have been updated to align with the new SOP on Human Subjects Research. They all help determine if your project is research with human subjects according to the federal regulations.
Expected impact High
Related changes See the new SOP and worksheet listed above.
Link for more information See the documents themselves, and see the eNews article above.
Implementation date

June 28, 2013

 

Topic Is the UW the Right IRB for Review? (NEW)
Document(s) NEW: SOP Engagement; WORKSHEET Engagement; SOP Authorization Agreements; SOP Research Collaborations or Multiple Performance Sites; WORKSHEET IRB Review Options; SOP Transfer to Another UW IRB; SOP Transfer to or from A Non-UW IRB; FORM Transfer Study
Description These new documents will assist both HSD staff and researchers in determining institutional and individual engagement in a project, and which IRB should be involved in the review.
Expected impact High
Related changes None
Link for more information See the documents themselves, linked above, and the article in this eNews.
Implementation date

June 28, 2013

 

Topic Is the UW IRB the Right IRB for Review? (REVISED)
Document(s) REVISED: SOP Use of the UW IRB
Description Format updated.
Expected impact Low
Related changes New tools for determining engagement listed above.
Link for more information See the eNews article above.
Implementation date

June 28, 2013

 

Topic Apply for Review (REVISED)
Document(s) REVISED: FORM Center, Program or Training Grant; SOP Exempt Determination; FORM Exempt Status Request WORD and PDF
Description Updated instructions in the Center, Program or Training Grant form to relieve burden of supplying the entirety of the grant. Documents pertaining to exempt research updated to include new policies on what kinds of research can qualify for exempt status.
Expected impact High
Related changes None
Link for more information See the documents themselves, and the article on Grant Applications, and Eligibility for Exempt Status in this eNews.
Implementation date

June 28, 2013

 

Topic IRB/HSD Review Tools (NEW)
Document(s) NEW: WORKSHEET Human Subjects Regulations; SOP Funding Review; SOP IRB Member Conflict of Interest; SOP Expedited Review; WORKSHEET Expedited Review; SOP Subject Numbers
Description New tools to assist HSD staff and IRB members in the review process. Made available to researchers to assist in their understanding of the IRB review process and the wide breadth of regulatory considerations. 
Expected impact High
Related changes None
Link for more information See the documents themselves and the eNews articles regarding expedited review, and triage above.
Implementation date

June 28, 2013

 


 

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July 2, 2013

IN THIS ISSUE

Changes are Here!

New SOPs, Tools, and Policies

Summary of Policy Changes

New and Revised Documents

 


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